Job Title - Engineer III (Process and Product Engineer)
Location - Hayward, CA
Essential Duties and Responsibilities
• Design/configure, validate, and implement computer systems for use by Hayward personnel.
Contribute to global projects and rollouts when necessary.
• Maintain a master list of all computer system assets for the site with appropriate level of detail
(including GAMP category, risk levels, etc.).
• Train to become Data Integrity lead for the site.
• Write, review, analyze and revise Standard Operating Procedures (SOPs), as needed to meet
Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Lead and assist in Quality System records, including non-conformance (NCR) investigations,
corrective and preventive actions (CAPAs), and Change Control.
• Plans, schedules and leads cross-functional team in detailed phases of the engineering work on a
project. Ex. Equipment validation, system validation, process transfer etc.
• Perform data and statistical analysis.
• Utilize engineering tools to solve problems (e.g. FMEA, Finite Element Analysis, process modeling,
SPC, TPM, DMAIC, etc.)
• Study, investigate, and recommend techniques to improve existing processes and products including
equipment, material, or design.
Education/Experience
• Bachelor's degree in Engineering required.
• Minimum 5 years related experience.
• Must have experience, or training, and demonstrate proficiency in engineering disciplines (e.g.
computer aided design, total quality management (6Sigma), statistical methods, materials
science, design of experiments, software development, engineering materials) and metrology.
• Validation experience is preferred
Qualifications
• Successful track record of managing activities and cross-functional teams within the business
unit.
• Recognized as a technical expert by peers and other personnel within the business unit.
• Must be able to provide solutions that reflect understanding of business objectives and cost
implications.
• Knowledge of cGMPs, FDA guidelines , Quality Operations, Quality Systems, Procurement
practices, and Equipment/Process validation.
• Working knowledge of lean manufacturing techniques and lean ergonomics is desired.
• Regular attendance is necessary to perform the essential functions of the job.
• Proficient in relevant products or process development processes.
• Light work, frequent lifting up to 25 lbs; frequent standing/walking
Thank you,
PandoLogic. Keywords: Process Engineer, Location: Hayward, CA - 94557